NCT06152094

Brief Summary

The BP Activate Study aims to assess the effectiveness of the BP Report letter with personalized BP medication recommendations, compared with Control letters and no intervention, at shortening time to appointment, time to visit, time to medication change, and time to achievement of BP goal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

November 21, 2023

Last Update Submit

January 24, 2025

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Time to medication change or demonstrated BP control at 6 months

    Time is measured as number of days between randomization date and the day that a participant is prescribed a new anti-HTN medication or an increase in dose of a prior anti-HTN medication, or they have a documented BP measurement \<140 mmHg systolic and \<90 mmHg diastolic.

    6 months

Secondary Outcomes (7)

  • Time to medication change or demonstrated BP control at 3 months

    3 months

  • Time to completed visit at 3 months

    3 months

  • Time to BP goal at 3 months

    3 months

  • Time to medication change at 3 months

    3 months

  • Time to completed visit at 6 months

    6 months

  • +2 more secondary outcomes

Study Arms (3)

BP Activate Letter

EXPERIMENTAL

Participants in the BP Activate Letter arm will receive a BP Report letter that includes computerized algorithm recommendations for medication changes they should discuss with their clinician.

Other: BP Activate Letter

Control Letter

ACTIVE COMPARATOR

Participants in the Control Letter arm will receive a Control letter suggesting they talk to their clinician about their blood pressure (without BP history or specific medication recommendations).

Other: Control Letter

Usual Care

NO INTERVENTION

Participants in the Usual Care arm will not receive any letter or any other intervention.

Interventions

BP Activate LetterOTHER

Participants in the BP Activate Letter arm will receive a BP Activate Report that includes personalized details about recent measurements, current medications, and "computer-generated medication recommendations that might improve your blood pressure", along with a log for tracking additional SMBP measurements. They will also receive a cover letter that includes an assessment that BP appears to be uncontrolled, and suggesting a visit with their provider to discuss.

BP Activate Letter
Control LetterOTHER

Participants in the Control Letter arm will receive a cover letter that includes an assessment that BP appears to be uncontrolled, and suggesting a visit with their provider to discuss.

Control Letter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is a primary care patient of a clinician in a general internal medicine clinic who has agreed to have their patients participate in the study
  • Lowest SBP\>140 or lowest DBP\>90 at last visit in general internal medicine clinic
  • Last visit in general internal medicine clinic was \< 2 years ago
  • EngageRx algorithm determines that a medication intensification step is indicated

You may not qualify if:

  • Primary language is not English
  • Patient's provider indicates (through an active opt-out process) that they do not want the patient to receive a BP Activate letter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Mark Pletcher, MD MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2023

First Posted

November 30, 2023

Study Start

July 20, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)